Blood Flow Restriction Training for Lower Leg Fractures

This study is looking at how using a special device called Blood Flow Restriction (BFR) during exercise might help people with broken lower leg bones (tibial shaft fractures) heal better. You would either do exercises with the BFR device, which gently restricts blood flow to your leg, or do exercises without it, which is the usual way. Researchers want to see if using BFR helps with muscle strength, muscle size, how well your fracture heals, and how quickly you get back to your normal activities. They will check on your fracture healing at 6 weeks, 12 weeks, and 6 months. This study is for adults aged 18 to 100 who have a closed tibial shaft fracture and can start physical therapy within two weeks of their injury. The study is currently recruiting 40 participants, but its overall status is unclear.

Study design
This is an interventional study where participants with tibial shaft fractures will be assigned to one of two groups: one using a blood flow restriction device during exercise, and one doing standard exercise. It aims to enroll 40 participants.
What's involved
You would perform exercises as guided by a physical therapist, either with or without a blood flow restriction device. Your fracture healing will be measured at 6 weeks, 12 weeks, and 6 months.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for fracture healing at 6 weeks, 12 weeks, and 6 months after treatment.

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NCT06496035

Blood Flow Restriction Training in Patients With Lower Extremity Fractures

Recruiting
NAAges 18+InterventionalTreatment
Denver Health and Hospital Authority
~40 participants
Updated 2025-11-21 on ClinicalTrials.gov
What's tested:Blood Flow Restriction with low load exerciseTherapeutic Exercise

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Fracture healing
Measured over 6 weeks, 12 weeks, 6 months
Tibial Fractures
Lower Extremity Fracture
1 sites across 1 states
Colorado1
  • Megan E Smith, PT, DPT · PRINCIPAL_INVESTIGATOR · Denver Health

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Eligibility criteria

Inclusion

Adult with closed tibial shaft fracture
Ability to begin physical therapy treatment within 2 weeks post-operatively

Exclusion

History of osteoporosis or osteopenia
Impaired circulation in the limb
Active deep vein thrombosis
Clotting disorders or other elevated risk of embolism
Sickle cell anemia
Infection in extremity
Renal compromise
Severe uncontrolled hypertension (SBP\>180)
Lymphedema
Under age 18
Pregnancy
Prisoner
  • Fracture healing6 weeks, 12 weeks, 6 months

    Tibial shaft fracture healing as measured by Radiographic Union Score for Tibial (RUST) fractures